DynaMag™ 16-2mL Tube Dx

Basic Information

• Brand Name: DynaMag™ 16-2mL Tube Dx
• Primary DI: 10190302006002
• Version / Model: A31346
• Company Name: LIFE TECHNOLOGIES CORPORATION
• Labeler DUNS: 080131636
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-06-26
• Public Version: 4
• Public Version Date: 2021-11-10
• Public Version Status: Update
• Public Device Record Key: 145be55d-243f-4947-969a-9947fb3df563

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PFT	Reagents for molecular diagnostic test systems	Clinical Chemistry	862.3800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60115	Magnetic cell separation magnet	A device featuring a permanent magnet designed to be used for the magnetic separation of specific cell types or subpopulations from heterogeneous human cell preparations. It typically functions in combination with a magnetizing reagent and buffered solution to separate the target cell population by retention in a magnetic field. This device is typically used in regenerative and in vitro fertilization (IVF)/assisted reproduction technique (ART) medicine, or during diagnostic testing of specific cell populations to support diagnosis of certain conditions. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10190302006002	GS1